Performing an audit demands meticulous planning—especially in the pharmaceutical world where we schedule everything down to the minute. We block out calendars, confirm facility access, and coordinate interviews. When an audit is planned, everyone adjusts
Reading time: ~5 minutes The Setup I was in Japan, auditing a major pharmaceutical site: multiple production buildings, a sprawling warehouse, and a bustling QC lab with about 150 staff. The company was top‑tier—every process was
Reading time: ~5 minutes The Unexpected Start It’s rare, but it happens: you walk into a site expecting a smooth audit—and instead get blank stares. That’s exactly what happened on a chilly morning in Germany.
An auditor’s story of charm, cigars, and unwavering integrity. 🇯🇵 Gifts by Courtesy — Not by Compliance In cultures like Japan, professionals offer polite, inexpensive gifts—like our 50‑cent porcelain Dutch clogs—as a token of respect.
In the world of pharmaceutical audits, maintaining a calm and open atmosphere is key. People are more forthcoming when they feel at ease. However, sometimes, despite our best efforts, tensions can escalate. One such incident
Introduction In the pharmaceutical industry, maintaining the integrity of medicinal products is paramount. As a Responsible Person (RP) in a pharmaceutical warehouse, I encountered a situation that underscored the importance of strict adherence to Good
Pest control isn’t just a checkbox in pharmaceutical audits—it’s a cornerstone of compliance. Many audit templates even require it as a standalone topic, and for good reason. Keeping rodents and pests away from medicinal products